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This is VAERS ID 323430

History of Changes from the VAERS Wayback Machine

First Appeared on 12/31/2008

VAERS ID: 323430
VAERS Form:
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 RA / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C2734AA / 0 LA / IM

Administered by: Other      Purchased by: Unknown
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Activities of daily living impaired, Antinuclear antibody positive

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus ex
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possibl
CDC 'Split Type':

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (n"ot including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other


Changed on 12/8/2009

VAERS ID: 323430 Before After
VAERS Form:
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 RA / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C2734AA / 0 LA / IM

Administered by: Other      Purchased by: Unknown Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Ataxia, Axonal neuropathy, Biopsy muscle abnormal, Blood immunoglobulin G increased, Blood immunoglobulin M, Blood product transfusion, Chest X-ray abnormal, Computerised tomogram normal, Constipation, Cough, CSF culture negative, CSF glucose normal, CSF oligoclonal band absent, CSF protein normal, Dehydration, Depression, Dysarthria, Dysphagia, Dysphonia, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ST segment depression, Electromyogram abnormal, Fatigue, Guillain-Barre syndrome, Headache, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Musculoskeletal pain, Nausea, Neck pain, Nerve conduction studies abnormal, Nervous system disorder, Neuromyopathy, Nuclear magnetic resonance imaging brain abnormal, Pneumonia aspiration, Progressive bulbar palsy, Red blood cells CSF positive, Respiratory failure, Tachycardia, Red blood cell sedimentation rate normal, Dysstasia, Activities of daily living impaired, Facial paresis, Gastrointestinal tube insertion, Neurological examination abnormal, Virus serology test positive, CSF test normal, Antinuclear antibody positive, Motor dysfunction, Pulmonary function test abnormal, Oral intake reduced

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus ex excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possibl
CDC 'Split Type': (blank) WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (n"ot (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillaine Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axona


Changed on 7/31/2010

VAERS ID: 323430 Before After
VAERS Form:
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 RA / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C2734AA / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Ataxia, Axonal neuropathy, Biopsy muscle abnormal, Blood immunoglobulin G increased, Blood immunoglobulin M, Blood product transfusion, Chest X-ray abnormal, Computerised tomogram normal, Constipation, Cough, CSF culture negative, CSF glucose normal, CSF oligoclonal band absent, CSF protein normal, Dehydration, Depression, Dysarthria, Dysphagia, Dysphonia, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ST segment depression, Electromyogram abnormal, Fatigue, Guillain-Barre syndrome, Headache, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Musculoskeletal pain, Nausea, Neck pain, Nerve conduction studies abnormal, Nervous system disorder, Neuromyopathy, Nuclear magnetic resonance imaging brain abnormal, Pneumonia aspiration, Progressive bulbar palsy, Red blood cells CSF positive, Respiratory failure, Tachycardia, Red blood cell sedimentation rate normal, Dysstasia, Activities of daily living impaired, Facial paresis, Gastrointestinal tube insertion, Neurological examination abnormal, Virus serology test positive, CSF test normal, Antinuclear antibody positive, Motor dysfunction, Pulmonary function test abnormal, Oral intake reduced

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possibl
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillaine Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axona


Changed on 8/31/2010

VAERS ID: 323430 Before After
VAERS Form:
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 RA / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C2734AA / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Electrocardiogram ST segment depression, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Progressive bulbar palsy, Respiratory failure, Neurological examination abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possibl
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillaine Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axona


Changed on 1/4/2011

VAERS ID: 323430 Before After
VAERS Form:
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 RA / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C2734AA / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Electrocardiogram ST segment depression, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Progressive bulbar palsy, Respiratory failure, Neurological examination abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possibl possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillaine Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axona axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the head or off the bed, difficulty lifting LE off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved LE weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her head. Approx 3 weeks after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her head w/o LOC. Had neck & shoulder discomfort. 3 weeks later was unable to raise arms above her head & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level


Changed on 4/13/2011

VAERS ID: 323430 Before After
VAERS Form:
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 RA / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C2734AA / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Ataxia, Axonal neuropathy, Biopsy muscle abnormal, Blood immunoglobulin G increased, Blood immunoglobulin M, Blood product transfusion, Chest X-ray abnormal, Computerised tomogram normal, Constipation, Cough, CSF culture negative, CSF glucose normal, CSF oligoclonal band absent, CSF protein normal, Dehydration, Depression, Dysarthria, Dysphagia, Dysphonia, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ST segment depression, Electromyogram abnormal, Fatigue, Guillain-Barre syndrome, Headache, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Musculoskeletal pain, Nausea, Neck pain, Nerve conduction studies abnormal, Nervous system disorder, Neuromyopathy, Nuclear magnetic resonance imaging brain abnormal, Pneumonia aspiration, Progressive bulbar palsy, Red blood cells CSF positive, Respiratory failure, Tachycardia, Red blood cell sedimentation rate normal, Dysstasia, Activities of daily living impaired, Facial paresis, Gastrointestinal tube insertion, Neurological examination abnormal, Virus serology test positive, CSF test normal, Antinuclear antibody positive, Motor dysfunction, Pulmonary function test abnormal, Oral intake reduced

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillaine Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the head or off the bed, difficulty lifting LE off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved LE weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her head. Approx 3 weeks after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her head w/o LOC. Had neck & shoulder discomfort. 3 weeks later was unable to raise arms above her head & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level


Changed on 5/13/2011

VAERS ID: 323430 Before After
VAERS Form:
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 RA / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C2734AA / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Ataxia, Axonal neuropathy, Biopsy muscle abnormal, Blood immunoglobulin G increased, Blood immunoglobulin M, Blood product transfusion, Chest X-ray abnormal, Computerised tomogram normal, Constipation, Cough, CSF culture negative, CSF glucose normal, CSF oligoclonal band absent, CSF protein normal, Dehydration, Depression, Dysarthria, Dysphagia, Dysphonia, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ST segment depression, Electromyogram abnormal, Fatigue, Guillain-Barre syndrome, Headache, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Musculoskeletal pain, Nausea, Neck pain, Nerve conduction studies abnormal, Nervous system disorder, Neuromyopathy, Nuclear magnetic resonance imaging brain abnormal, Pneumonia aspiration, Progressive bulbar palsy, Red blood cells CSF positive, Respiratory failure, Tachycardia, Red blood cell sedimentation rate normal, Dysstasia, Activities of daily living impaired, Facial paresis, Gastrointestinal tube insertion, Neurological examination abnormal, Virus serology test positive, CSF test normal, Antinuclear antibody positive, Motor dysfunction, Pulmonary function test abnormal, Oral intake reduced

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillaine Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the head or off the bed, difficulty lifting LE off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved LE weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her head. Approx 3 weeks after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her head w/o LOC. Had neck & shoulder discomfort. 3 weeks later was unable to raise arms above her head & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level


Changed on 6/11/2011

VAERS ID: 323430 Before After
VAERS Form:
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 RA / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C2734AA / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Ataxia, Axonal neuropathy, Biopsy muscle abnormal, Blood immunoglobulin G increased, Blood immunoglobulin M, Blood product transfusion, Chest X-ray abnormal, Computerised tomogram normal, Constipation, Cough, CSF culture negative, CSF glucose normal, CSF oligoclonal band absent, CSF protein normal, Dehydration, Depression, Dysarthria, Dysphagia, Dysphonia, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ST segment depression, Electromyogram abnormal, Fatigue, Guillain-Barre syndrome, Headache, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Musculoskeletal pain, Nausea, Neck pain, Nerve conduction studies abnormal, Nervous system disorder, Neuromyopathy, Nuclear magnetic resonance imaging brain abnormal, Pneumonia aspiration, Progressive bulbar palsy, Red blood cells CSF positive, Respiratory failure, Tachycardia, Red blood cell sedimentation rate normal, Dysstasia, Activities of daily living impaired, Facial paresis, Gastrointestinal tube insertion, Neurological examination abnormal, Virus serology test positive, CSF test normal, Antinuclear antibody positive, Motor dysfunction, Pulmonary function test abnormal, Oral intake reduced

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillaine Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the head or off the bed, difficulty lifting LE off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved LE weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her head. Approx 3 weeks after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her head w/o LOC. Had neck & shoulder discomfort. 3 weeks later was unable to raise arms above her head & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level


Changed on 2/13/2013

VAERS ID: 323430 Before After
VAERS Form:
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 RA / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C2734AA / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Ataxia, Axonal neuropathy, Biopsy muscle abnormal, Blood immunoglobulin G increased, Blood immunoglobulin M, Blood product transfusion, Chest X-ray abnormal, Computerised tomogram normal, Constipation, Cough, CSF culture negative, CSF glucose normal, CSF oligoclonal band absent, CSF protein normal, Dehydration, Depression, Dysarthria, Dysphagia, Dysphonia, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ST segment depression, Electromyogram abnormal, Fatigue, Guillain-Barre syndrome, Headache, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Musculoskeletal pain, Nausea, Neck pain, Nerve conduction studies abnormal, Nervous system disorder, Neuromyopathy, Nuclear magnetic resonance imaging brain abnormal, Pneumonia aspiration, Progressive bulbar palsy, Red blood cells CSF positive, Respiratory failure, Tachycardia, Red blood cell sedimentation rate normal, Dysstasia, Activities of daily living impaired, Facial paresis, Gastrointestinal tube insertion, Neurological examination abnormal, Virus serology test positive, CSF test normal, Antinuclear antibody positive, Motor dysfunction, Pulmonary function test abnormal, Oral intake reduced

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillaine Guillain Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the head [[name]] or off the bed, difficulty lifting LE [[name]] off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved LE [[name]] weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her head. [[name]]. Approx 3 weeks [[name]] after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her head [[name]] w/o LOC. Had neck & shoulder discomfort. 3 weeks [[name]] later was unable to raise arms above her head [[name]] & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level subseque


Changed on 6/14/2014

VAERS ID: 323430 Before After
VAERS Form:
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 RA / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C2734AA / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Ataxia, Axonal neuropathy, Biopsy muscle abnormal, Blood immunoglobulin G increased, Blood immunoglobulin M, Blood product transfusion, Chest X-ray abnormal, Computerised tomogram normal, Constipation, Cough, CSF culture negative, CSF glucose normal, CSF oligoclonal band absent, CSF protein normal, Dehydration, Depression, Dysarthria, Dysphagia, Dysphonia, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ST segment depression, Electromyogram abnormal, Fatigue, Guillain-Barre syndrome, Headache, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Musculoskeletal pain, Nausea, Neck pain, Nerve conduction studies abnormal, Nervous system disorder, Neuromyopathy, Nuclear magnetic resonance imaging brain abnormal, Pneumonia aspiration, Progressive bulbar palsy, Red blood cells CSF positive, Respiratory failure, Tachycardia, Red blood cell sedimentation rate normal, Dysstasia, Activities of daily living impaired, Facial paresis, Gastrointestinal tube insertion, Neurological examination abnormal, Virus serology test positive, CSF test normal, Antinuclear antibody positive, Motor dysfunction, Pulmonary function test abnormal, Oral intake reduced

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillain Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the [[name]] or off the bed, difficulty lifting [[name]] off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved [[name]] weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her [[name]]. Approx 3 [[name]] after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her [[name]] w/o LOC. Had neck & shoulder discomfort. 3 [[name]] later was unable to raise arms above her [[name]] & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subseque


Changed on 8/14/2014

VAERS ID: 323430 Before After
VAERS Form:
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 RA / IM
TDAP: TDAP (NO BRAND NAME) TDAP (ADACEL) / UNKNOWN MANUFACTURER SANOFI PASTEUR C2734AA / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Ataxia, Axonal neuropathy, Biopsy muscle abnormal, Blood immunoglobulin G increased, Blood immunoglobulin M, Blood product transfusion, Chest X-ray abnormal, Computerised tomogram normal, Constipation, Cough, CSF culture negative, CSF glucose normal, CSF oligoclonal band absent, CSF protein normal, Dehydration, Depression, Dysarthria, Dysphagia, Dysphonia, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ST segment depression, Electromyogram abnormal, Fatigue, Guillain-Barre syndrome, Headache, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Musculoskeletal pain, Nausea, Neck pain, Nerve conduction studies abnormal, Nervous system disorder, Neuromyopathy, Nuclear magnetic resonance imaging brain abnormal, Pneumonia aspiration, Progressive bulbar palsy, Red blood cells CSF positive, Respiratory failure, Tachycardia, Red blood cell sedimentation rate normal, Dysstasia, Activities of daily living impaired, Facial paresis, Gastrointestinal tube insertion, Neurological examination abnormal, Virus serology test positive, CSF test normal, Antinuclear antibody positive, Motor dysfunction, Pulmonary function test abnormal, Oral intake reduced

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillain Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the [[name]] or off the bed, difficulty lifting [[name]] off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved [[name]] weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her [[name]]. Approx 3 [[name]] after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her [[name]] w/o LOC. Had neck & shoulder discomfort. 3 [[name]] later was unable to raise arms above her [[name]] & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subseque


Changed on 4/14/2017

VAERS ID: 323430 Before After
VAERS Form:
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 0 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2734AA / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Ataxia, Axonal neuropathy, Biopsy muscle abnormal, Blood immunoglobulin G increased, Blood immunoglobulin M, Blood product transfusion, Chest X-ray abnormal, Computerised tomogram normal, Constipation, Cough, CSF culture negative, CSF glucose normal, CSF oligoclonal band absent, CSF protein normal, Dehydration, Depression, Dysarthria, Dysphagia, Dysphonia, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ST segment depression, Electromyogram abnormal, Fatigue, Guillain-Barre syndrome, Headache, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Musculoskeletal pain, Nausea, Neck pain, Nerve conduction studies abnormal, Nervous system disorder, Neuromyopathy, Nuclear magnetic resonance imaging brain abnormal, Pneumonia aspiration, Progressive bulbar palsy, Red blood cells CSF positive, Respiratory failure, Tachycardia, Red blood cell sedimentation rate normal, Dysstasia, Activities of daily living impaired, Facial paresis, Gastrointestinal tube insertion, Neurological examination abnormal, Virus serology test positive, CSF test normal, Antinuclear antibody positive, Motor dysfunction, Pulmonary function test abnormal, Oral intake reduced

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillain Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the [[name]] or off the bed, difficulty lifting [[name]] off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved [[name]] weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her [[name]]. Approx 3 [[name]] after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her [[name]] w/o LOC. Had neck & shoulder discomfort. 3 [[name]] later was unable to raise arms above her [[name]] & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subseque subsequently transferred to


Changed on 9/14/2017

VAERS ID: 323430 Before After
VAERS Form:(blank) 1
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 0 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2734AA / 0 1 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Respiratory failure

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillain Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the [[name]] or off the bed, difficulty lifting [[name]] off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved [[name]] weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her [[name]]. Approx 3 [[name]] after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her [[name]] w/o LOC. Had neck & shoulder discomfort. 3 [[name]] later was unable to raise arms above her [[name]] & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level of care.


Changed on 2/14/2018

VAERS ID: 323430 Before After
VAERS Form:1
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2734AA / 1 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Respiratory failure

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillain Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the [[name]] or off the bed, difficulty lifting [[name]] off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved [[name]] weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her [[name]]. Approx 3 [[name]] after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her [[name]] w/o LOC. Had neck & shoulder discomfort. 3 [[name]] later was unable to raise arms above her [[name]] & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level of care.


Changed on 6/14/2018

VAERS ID: 323430 Before After
VAERS Form:1
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2734AA / 1 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Respiratory failure

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillain Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the [[name]] or off the bed, difficulty lifting [[name]] off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved [[name]] weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her [[name]]. Approx 3 [[name]] after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her [[name]] w/o LOC. Had neck & shoulder discomfort. 3 [[name]] later was unable to raise arms above her [[name]] & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level of care.


Changed on 8/14/2018

VAERS ID: 323430 Before After
VAERS Form:1
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2734AA / 1 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Respiratory failure

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillain Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the [[name]] or off the bed, difficulty lifting [[name]] off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved [[name]] weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her [[name]]. Approx 3 [[name]] after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her [[name]] w/o LOC. Had neck & shoulder discomfort. 3 [[name]] later was unable to raise arms above her [[name]] & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level of care.


Changed on 9/14/2018

VAERS ID: 323430 Before After
VAERS Form:1
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2734AA / 1 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Respiratory failure

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillain Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the [[name]] or off the bed, difficulty lifting [[name]] off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved [[name]] weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her [[name]]. Approx 3 [[name]] after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her [[name]] w/o LOC. Had neck & shoulder discomfort. 3 [[name]] later was unable to raise arms above her [[name]] & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level of care.


Changed on 10/14/2018

VAERS ID: 323430 Before After
VAERS Form:1
Age:20.0
Sex:Female
Location:Utah
Vaccinated:2007-07-13
Onset:2008-04-01
Submitted:2008-08-26
Entered:2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2734AA / 1 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Respiratory failure

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2008-08-21
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 15     Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC 'Split Type': WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillain Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the [[name]] or off the bed, difficulty lifting [[name]] off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved [[name]] weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her [[name]]. Approx 3 [[name]] after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her [[name]] w/o LOC. Had neck & shoulder discomfort. 3 [[name]] later was unable to raise arms above her [[name]] & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level of care.

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